About TAVNEOS® (avacopan) | TAVNEOS
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TAVNEOS in combination with additional immunosuppressive therapy* was comparable to standard therapy at reaching remission at 6 months, and superior at sustaining remission at 1 year.

TAVNEOS® (avacopan) is not a steroid. It is a targeted therapy that was designed to block a receptor involved inANCA-associated vasculitis.

  • TAVNEOS blocks the interaction of a receptor on an immune cell in your body (called a neutrophil) and a protein called C5a
  • When C5a binds to the C5a receptor (C5aR) on neutrophils, C5aR-activated neutrophils play a role in the
    inflammationThe body's reaction to injury or infection. It is characterized by swelling, heat, redness, and pain.
     of small to medium-sized blood vessels
  • This C5a-C5aR interaction is believed to be a crucial part of the development of ANCA-associated vasculitis, and by blocking it, TAVNEOS may help reduce inflammation
  • The precise mechanism by which TAVNEOS works in ANCA-associated vasculitis has not been definitively established
TAVNEOS was studied in a clinical trial that aimed to test whether participants could achieve and sustain remissionThe period in which a disease and its symptoms decreases or subsides.. To test this, trial participants were given either TAVNEOS in combination with immunosuppressive therapy* or standard therapy alone.

TAVNEOS in combination with additional immunosuppressive therapy* was comparable to standard therapy alone at reaching remission at 6 months and was superior at sustaining remission at 1 year.

TAVNEOS was studied in a clinical trial involving 330 adults living with ANCA-associated vasculitis over 52 weeks

Remission rates at 6 months and 12 months graphic (72% with TAVNEOS vs. 70% and 66% with TAVNEOS vs. 55%, respectively)

*Immunosuppressive therapy: rituximab or cyclophosphamide followed by azathioprine

Standard therapy: immunosuppressive therapy and a gradual reduction of prednisone over time

Talk to your doctor about adding TAVNEOS today

Talk to
 your doctor 

about adding TAVNEOS today if you’re still
experiencing signs and symptoms of
ANCA-associated vasculitis.

Talk to your doctor about adding TAVNEOS today

What are the most common side effects of TAVNEOS?

The most common side effects are nausea, headache, high blood pressure, diarrhea, vomiting, rash, tiredness, stomach pain, dizziness, increase in blood creatinine, and burning or prickling sensation. However, these are not all of the possible side effects that may occur with TAVNEOS.

Who should not take TAVNEOS?

Do not take TAVNEOS if you are allergic to avacopan or any of the other ingredients of this medicine. See the Medication Guide for a complete list of the ingredients in TAVNEOS.

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Seek medical help immediately if you experience any of the following:

  • Swollen lips/tongue/throat
  • Trouble swallowing
  • Difficulty breathing

These could be signs of an allergic reaction. Do not take any more TAVNEOS until you have consulted with your healthcare provider.

Important Safety Information

What is the most important information I should know about TAVNEOS?

TAVNEOS can cause serious side effects, including:

  • Liver problems. People taking TAVNEOS may have serious liver problems. Call your healthcare provider right away if you have unexplained symptoms such as:
  • yellowing of your skin or the white part of your eyes (jaundice)
  • pain on the upper right side of your stomach area (abdomen)
  • feeling tired
  • dark or brown (tea colored) urine
  • bleeding or bruising more easily than normal
  • loss of appetite
  • yellowing of your skin or the white part of your eyes (jaundice)
  • dark or brown (tea colored) urine
  • pain on the upper right side of your stomach area (abdomen)
  • bleeding or bruising more easily than normal
  • feeling tired
  • loss of appetite

Your healthcare provider will do blood tests to check how well your liver is working before starting and during your treatment with TAVNEOS.

Do not take TAVNEOS if you are allergic to avacopan or any of the other ingredients in TAVNEOS.

  • Get medical help right away if you experience swollen lips, tongue, throat, trouble swallowing, or difficulty breathing. These could be signs of an allergic reaction. Do not take more TAVNEOS until you have consulted with your healthcare provider.

Before taking TAVNEOS, tell your healthcare provider about all your medical conditions, including if you:

  • have or have had abnormal liver blood tests.
  • have or have had liver problems.
  • have or think you may have hepatitis B or C.
  • have an infection.
  • are pregnant or are planning to become pregnant. It is not known if TAVNEOS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if TAVNEOS can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take TAVNEOS.

Tell your healthcare provider about all the other medicines you take,

including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAVNEOS and certain other medicines may affect each other and cause side effects. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist.

  • Some medicines should not be taken with TAVNEOS.
  • Your healthcare provider may prescribe other medicines to treat your disease.

TAVNEOS may cause serious side effects, including:

  • Liver problems (see above).
  • Serious allergic reactions. Stop taking TAVNEOS and get emergency medical help right away if you have any of the following signs of a serious allergic reaction: shortness of breath or trouble breathing; swollen lips, tongue, throat, or face; trouble swallowing; chest pain; feeling dizzy or faint; moderate or severe abdominal pain, or vomiting.
  • Hepatitis B virus (HBV) reactivation. If you have had HBV or are a carrier of HBV, taking TAVNEOS could cause the virus to become an active infection again. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or the white part of your eyes during treatment with TAVNEOS.
  • Serious infections. Serious infections can happen in people taking TAVNEOS, and these infections can lead to death. The most common serious infections with TAVNEOS were pneumonia and urinary tract infections. People with serious infections should not take TAVNEOS. Tell your healthcare provider right away if you have any symptoms of infection: fever, cold symptoms that do not go away, flu symptoms, pain during urination, or other signs of infection.

The most common side effects of TAVNEOS include:

  • nausea, headache, high blood pressure, diarrhea, vomiting, rash, tiredness, stomach pain, dizziness, increase in blood creatinine, and burning or prickling sensation.

What is TAVNEOS?

TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody(ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [MPA]).

It is not known if TAVNEOS is safe and effective in children under the age of 18.

These are not all the possible side effects of TAVNEOS. Call your doctor for medical advice about side effects. Please see the Full Prescribing Information and Medication Guide for further details.

TAVNEOS is available as a 10 mg capsule.

You are encouraged to report negative side effects to 1-833-828-6367 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-332-1088.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TAVNEOS?

TAVNEOS can cause serious side effects, including:

  • Liver problems. People taking TAVNEOS may have serious liver problems.
    Call your healthcare provider right away if you have unexplained symptoms such as:

What is TAVNEOS?

TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active